BRPI0504445A - composição de trombina e processo para a sua preparação - Google Patents

composição de trombina e processo para a sua preparação

Info

Publication number
BRPI0504445A
BRPI0504445A BRPI0504445-6A BRPI0504445A BRPI0504445A BR PI0504445 A BRPI0504445 A BR PI0504445A BR PI0504445 A BRPI0504445 A BR PI0504445A BR PI0504445 A BRPI0504445 A BR PI0504445A
Authority
BR
Brazil
Prior art keywords
preparation
thrombin
thrombin composition
stable
composition
Prior art date
Application number
BRPI0504445-6A
Other languages
English (en)
Inventor
Juan Ignacio Jorquera Nieto
Pere Ristol Debart
Jesus Fernandez Rodriguez
Isabel Bravo Camison
Rafael Lopez Gomez
Original Assignee
Grifols Sa
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=34384852&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=BRPI0504445(A) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Grifols Sa filed Critical Grifols Sa
Publication of BRPI0504445A publication Critical patent/BRPI0504445A/pt

Links

Classifications

    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12NMICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N9/00Enzymes; Proenzymes; Compositions thereof; Processes for preparing, activating, inhibiting, separating or purifying enzymes
    • C12N9/96Stabilising an enzyme by forming an adduct or a composition; Forming enzyme conjugates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/43Enzymes; Proenzymes; Derivatives thereof
    • A61K38/46Hydrolases (3)
    • A61K38/48Hydrolases (3) acting on peptide bonds (3.4)
    • A61K38/482Serine endopeptidases (3.4.21)
    • A61K38/4833Thrombin (3.4.21.5)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00Drugs for disorders of the blood or the extracellular fluid
    • A61P7/04Antihaemorrhagics; Procoagulants; Haemostatic agents; Antifibrinolytic agents
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12NMICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N9/00Enzymes; Proenzymes; Compositions thereof; Processes for preparing, activating, inhibiting, separating or purifying enzymes
    • C12N9/14Hydrolases (3)
    • C12N9/48Hydrolases (3) acting on peptide bonds (3.4)
    • C12N9/50Proteinases, e.g. Endopeptidases (3.4.21-3.4.25)
    • C12N9/64Proteinases, e.g. Endopeptidases (3.4.21-3.4.25) derived from animal tissue
    • C12N9/6421Proteinases, e.g. Endopeptidases (3.4.21-3.4.25) derived from animal tissue from mammals
    • C12N9/6424Serine endopeptidases (3.4.21)
    • C12N9/6429Thrombin (3.4.21.5)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/02Inorganic compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/42Proteins; Polypeptides; Degradation products thereof; Derivatives thereof, e.g. albumin, gelatin or zein

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Organic Chemistry (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Zoology (AREA)
  • Wood Science & Technology (AREA)
  • Genetics & Genomics (AREA)
  • Biomedical Technology (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Engineering & Computer Science (AREA)
  • Molecular Biology (AREA)
  • Biotechnology (AREA)
  • Microbiology (AREA)
  • Biochemistry (AREA)
  • Epidemiology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Immunology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Diabetes (AREA)
  • Hematology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
  • Materials For Medical Uses (AREA)

Abstract

"COMPOSIçãO DE TROMBINA E PROCESSO PARA A SUA PREPARAçãO". Uma composição de trombina estável compreende trombina purificada, albumina humana e um sal neutro, sendo o produto resultante estável quando armazenado como um liofilizado ou congelado e é ajustado para uma intensidade nominal de 500 IU de trombina, ou mais, por ml de solução, estando a albumina humana em uma concentração de mais que 0,05% (p/v) e, preferentemente, entre 0,1% (p/v) e 1% (p/v).
BRPI0504445-6A 2004-10-22 2005-10-21 composição de trombina e processo para a sua preparação BRPI0504445A (pt)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
ES200402523A ES2226587B1 (es) 2004-10-22 2004-10-22 Composicion de trombina estable.

Publications (1)

Publication Number Publication Date
BRPI0504445A true BRPI0504445A (pt) 2006-06-27

Family

ID=34384852

Family Applications (1)

Application Number Title Priority Date Filing Date
BRPI0504445-6A BRPI0504445A (pt) 2004-10-22 2005-10-21 composição de trombina e processo para a sua preparação

Country Status (14)

Country Link
US (2) US20060088518A1 (pt)
EP (1) EP1649867B8 (pt)
JP (1) JP5105734B2 (pt)
AR (1) AR051396A1 (pt)
AU (1) AU2005225085B2 (pt)
BR (1) BRPI0504445A (pt)
CA (1) CA2523844C (pt)
ES (2) ES2226587B1 (pt)
HU (1) HUE052760T2 (pt)
MX (1) MXPA05011283A (pt)
NZ (1) NZ543084A (pt)
PL (1) PL1649867T3 (pt)
PT (1) PT1649867T (pt)
UY (1) UY29172A1 (pt)

Families Citing this family (20)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
ES2775974T3 (es) * 2006-06-26 2020-07-28 Omrix Biopharmaceuticals Inc Eliminación de virus por nanofiltración
CA2716872C (en) 2008-02-29 2015-02-10 Ferrosan Medical Devices A/S Device for promotion of hemostasis and/or wound healing
JP5437236B2 (ja) 2008-04-16 2014-03-12 一般財団法人化学及血清療法研究所 トロンビン固定化生体吸収性シート製剤の製造方法
ES2682302T3 (es) 2010-06-01 2018-09-19 Baxter International Inc Proceso para la producción de composiciones hemostáticas secas y estables
JP5973997B2 (ja) 2010-06-01 2016-08-23 バクスター・インターナショナル・インコーポレイテッドBaxter International Incorp0Rated 乾燥した安定な止血用組成物を作製するためのプロセス
AU2011260260B2 (en) 2010-06-01 2015-09-03 Baxter Healthcare S.A. Process for making dry and stable hemostatic compositions
CN104159527B (zh) 2012-03-06 2017-04-12 弗罗桑医疗设备公司 包含止血糊剂的压力容器
RU2636240C2 (ru) 2012-06-12 2017-11-21 Ферросан Медикал Дивайсиз А/С Сухая гемостатическая композиция
US9149529B2 (en) 2012-10-24 2015-10-06 Orthovita, Inc. Stable compositions containing thrombin and methods for preparation and use thereof
NZ708737A (en) * 2012-12-03 2019-06-28 Omrix Biopharmaceuticals Ltd Thrombin solution and methods of use thereof
US9212357B2 (en) 2012-12-03 2015-12-15 Omrix Biopharmaceuticals Ltd. Thrombin solution and methods of use thereof
JP6390873B2 (ja) 2013-06-21 2018-09-19 フェッローサン メディカル ディバイス エー/エス 減圧膨張させた乾燥組成物およびそれを保持するためのシリンジ
BR112016013322B1 (pt) 2013-12-11 2020-07-21 Ferrosan Medical Devices A/S métodos para preparação de uma composição seca e para reconstituir uma composição seca, composição seca, uso de uma composição seca, e, kit
BR112017007466B1 (pt) 2014-10-13 2021-03-02 Ferrosan Medical Devices A/S método para preparar uma composição seca, método para reconstituir a composição seca, pasta, composição seca, recipiente, kit homeostático, e, uso de uma composição seca
RU2705905C2 (ru) 2014-12-24 2019-11-12 Ферросан Медикал Дивайсиз А/С Шприц для удерживания и смешивания первого и второго веществ
TW201702385A (zh) * 2015-03-13 2017-01-16 崇謹 孫 穩定凝血酶之方法及其組合物
CA2986981A1 (en) 2015-07-03 2017-01-12 Ferrosan Medical Devices A/S Syringe for mixing two components and for retaining a vacuum in a storage condition
EP4321182A3 (en) 2018-05-09 2024-05-29 Ferrosan Medical Devices A/S Method for preparing a haemostatic composition
CN118785918A (zh) 2021-12-23 2024-10-15 广州倍绣生物技术有限公司 喷雾干燥的凝血酶
CN118401262A (zh) 2021-12-30 2024-07-26 巴克斯特国际公司 用于纤维蛋白密封剂的纤维蛋白原和凝血酶溶液以及纤维蛋白密封剂试剂盒

Family Cites Families (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS5639782A (en) * 1979-09-04 1981-04-15 Dai Ichi Pure Chem Co Ltd Stabilization of thrombin
US4696812A (en) * 1985-10-28 1987-09-29 Warner-Lambert Company Thrombin preparations
JPS63243032A (ja) * 1987-03-27 1988-10-07 Green Cross Corp:The トロンビンの加熱処理方法
JPH0813750B2 (ja) 1990-03-01 1996-02-14 持田製薬株式会社 経口用トロンビン製剤
FR2679251B1 (fr) * 1991-07-18 1993-11-12 Nord Assoc Essor Transfusion San Procede de preparation d'un concentre de thrombine humaine destine a un usage therapeutique.
AU683834B2 (en) * 1991-12-31 1997-11-27 Zymogenetics Inc. Methods for producing thrombin
US5506127A (en) * 1994-09-21 1996-04-09 Proba; Zbigniew Therapeutic grade thrombin produced by chromatography
GB9503750D0 (en) * 1995-02-24 1995-04-12 Common Services Agency Thrombin preparation
JPH10215875A (ja) * 1997-02-06 1998-08-18 Mitsubishi Chem Corp 蛋白質の精製方法
US5981254A (en) * 1997-10-30 1999-11-09 Haemacure Corporation Process for producing thrombin from plasma
AU7320300A (en) * 1999-09-27 2001-04-30 International Reagents Corporation Means of stabilizing thrombin and compositions
DE10022092A1 (de) * 2000-05-08 2001-11-15 Aventis Behring Gmbh Stabilisiertes Protein-Präparat und Verfahren zu seiner Herstellung

Also Published As

Publication number Publication date
EP1649867B8 (en) 2021-09-08
HUE052760T2 (hu) 2021-05-28
ES2845143T3 (es) 2021-07-26
EP1649867B1 (en) 2020-11-25
AU2005225085A1 (en) 2006-05-11
EP1649867A1 (en) 2006-04-26
PL1649867T3 (pl) 2021-06-14
CA2523844C (en) 2012-06-19
ES2226587A1 (es) 2005-03-16
AU2005225085B2 (en) 2007-05-31
ES2226587B1 (es) 2005-12-16
JP5105734B2 (ja) 2012-12-26
PT1649867T (pt) 2021-02-03
AR051396A1 (es) 2007-01-10
UY29172A1 (es) 2006-04-28
CA2523844A1 (en) 2006-04-22
US20140322791A1 (en) 2014-10-30
MXPA05011283A (es) 2006-05-25
NZ543084A (en) 2007-03-30
ES2845143T8 (es) 2021-11-17
US9376674B2 (en) 2016-06-28
JP2006117678A (ja) 2006-05-11
US20060088518A1 (en) 2006-04-27

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Legal Events

Date Code Title Description
B25G Requested change of headquarter approved

Owner name: GRIFOLS, S.A. (ES)

B06F Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]
B07D Technical examination (opinion) related to article 229 of industrial property law [chapter 7.4 patent gazette]
B07E Notification of approval relating to section 229 industrial property law [chapter 7.5 patent gazette]
B07A Application suspended after technical examination (opinion) [chapter 7.1 patent gazette]
B09B Patent application refused [chapter 9.2 patent gazette]
B12B Appeal against refusal [chapter 12.2 patent gazette]
B15W Others matters related to applications: legal action concerning application

Free format text: INPI NO 52402.009734/2020-87 ORIGEM: JUIZO FEDERAL DA 9A VF DO RIO DE JANEIRO (TRF2) PROCESSO NO: 00408.055151/2020-74 (REF. 5046129-08.2020.4.02.5101) NULIDADE DO ATO ADMINISTRATIVO QUE MANTEVE O INDEFERIMENTO DO PEDIDO DE PATENTE AUTOR: GRIFOLS S.A. REU(S): INSTITUTO NACIONAL DA PROPRIEDADE INDUSTRIAL ? INPI